FDA Adverse Event
Injury
Summary report: N
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
MDR report key: 3092144
·
Received May 3, 2013
Report
- Report Number
- 3007566237-2013-01519
- Event Type
- Injury
- Date Received
- May 3, 2013
- Report Date
- April 17, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_EXT, PRODUCT TYPE: EXTENSION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE HEALTHCARE PROVIDER THOUGHT THE LEADS COULD BE "CAVERNOUS" AFTER SOME TIME.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT HAD A REVISION OF THEIR EXTENSION CABLE. THE CAUSE OF THE REVISION WAS UNKNOWN. IT WAS ALSO REPORTED THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 194631 | UNKNOWN IMPLANTABLE NEUROSTIMULATOR | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |